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Efficacy and Safety of Anthrax Vaccine, GC1109

NCT01867957 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-06-05

No results posted yet for this study

Summary

1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.
2. OBJECTIVE

\- To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.
3. STUDY DESIGN

* single-blinded
* randomized
* placebo controlled
* phase 1 study

Conditions

  • Anthrax

Interventions

BIOLOGICAL

Low-dose GC1109

50ug/dose

BIOLOGICAL

High-dose GC1109

100ug/dose

BIOLOGICAL

Low-dose Placebo

0.9% Saline 0.5 mL

BIOLOGICAL

High-dose Placebo

0.9% Saline 1.0 mL

Sponsors & Collaborators

  • Green Cross Corporation

    collaborator INDUSTRY

  • LSK Global Pharma Services Co. Ltd.

    collaborator UNKNOWN

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Myoung-don Oh, M.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867957 on ClinicalTrials.gov